The FDA approved Eli Lilly’s Emgality (galcanezumab-gnlm) for the preventative treatment of migraine in adults. This is the third FDA-approved biologic that acts by reducing the effect of CGRP, a molecule believed to play a role in migraine. Aimovig (erenumab-aooe) was approved on May 17, 2018 and Ajovy (fremanezumab-vfrm) was approved on September 14, 2018.
“Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment,” said Christi Shaw, president, Lilly Bio-Medicines. “For more than two decades, Lilly has recognized this unmet need, and we have worked tirelessly to develop a new option specifically designed for the prevention of migraine. With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease.”
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. Hypersensitivity reactions (e.g., rash, urticaria (hives), and dyspnea (shortness of breath)) have been reported with Emgality in clinical studies. The most common adverse reactions in Emgality clinical studies were injection site reactions, sinusitis, and urinary tract infection.
The efficacy and safety of Emgality was demonstrated in two Phase 3 clinical trials in patients with episodic migraine (Evolve-1 and Evolve-2) and one Phase 3 clinical trial in patients with chronic migraine (Regain).
Evolve-1 and Evolve-2 were six-month, double-blind, placebo-controlled studies that enrolled adult patients with episodic migraine (defined as 4-14 migraine headache days [MHDs] per month). Regain was a three-month, double-blind, placebo-controlled study that enrolled adult patients with chronic migraine (defined as at least 15 headache days per month with at least 8 MHDs per month).
In all three studies, patients were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. The primary endpoint was the mean change from baseline in the number of monthly MHDs over the double-blind treatment period in the intent-to-treat study population.
The U.S. list price of Emgality is $575 once-monthly, or $6,900 annually.